Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01)

The Food and Drug Administration announces its intention to consider and accept a single source application for award to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The purpose of this program is to provide support in convening leading global drug regulatory agencies and pharmaceutical manufacturer associations to achieve greater harmonization of technical standards to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. The outcome of this effort will be a series of guidelines internationally recognized and categorized into four main topics:1. Quality Guidelines: Harmonization achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.2. Safety Guidelines: A comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. 3. Efficacy Guidelines: The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety, and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.4. Multidisciplinary Guidelines: These are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the Common Technical Document (CTD), and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).